Lesinurad

(Bempedoic acid)

ApprovedSmall molecule

Bempedoic acid is used to lower uric acid levels in the blood to help prevent gout attacks, which cause sudden painful swelling in joints.[2] Lesinurad is currently approved and in use across 11 indications[4].[1]

Lesinurad is one of 206 small molecule programs targeting Atherosclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

205

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

AtherosclerosisActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

Inherited Lipid Metabolism DisorderActive, not recruiting

Abnormal Circulating Lipid ConcentrationActive, not recruiting

Disorder of Lipid MetabolismApproved

Autosomal Dominant Polycystic Kidney DiseaseApproved

Type 2 Diabetes MellitusRecruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

HypercholesterolemiaCompleted

EfficacyRecruiting

AtherosclerosisApproved

Active, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Inherited Lipid Metabolism DisorderApproved

Active, not recruiting

Abnormal Circulating Lipid ConcentrationApproved

Active, not recruiting

Disorder of Lipid MetabolismApproved

Approved

Autosomal Dominant Polycystic Kidney DiseaseApproved

Approved

Type 2 Diabetes MellitusApproved

Recruiting

Alcoholic Fatty Liver DiseasePreclinical

Active, not recruiting

HypercholesterolemiaApproved

Completed

EfficacyPhase 3

Recruiting

Competition

Competitive Landscape

150 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Lesinurad

EEsperion Therapeutics, Inc.

Approved

1 2

DWP16001

Daewoong Pharmaceutical Co. LTD.

Phase 3

5 3

Maridebart Cafraglutide

Amgen

Phase 3

3 4

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 5

Elecoglipron

AstraZeneca

Phase 3

5 6

Ganagliflozin

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

1 7

TG103

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Phase 3

2 8

Adenocard

Astellas

Preclinical

1 9

NOVOLIN R

Novo Nordisk

Preclinical

1 10

Dostinex

Pfizer

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Not yet recruiting

Prevention

NCT07239414

Q1 2028

Recruiting

Primary

NCT06686615

Phase 2Recruiting

Inflammation

NCT05488431

Q4 2028

Phase 3Not yet recruiting

Coronary Atherosclerosis

NCT07474649

ApprovedRecruiting

Acute Coronary Syndromes

NCT07824323

Recruiting

Treatment

NCT07374861

Clinical

Trials by Indication[1]

Hypercholesterolemia4 trials

A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT06925100·180 enrolled

A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT06450366·301 enrolled

SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT05546398·500 enrolled

Show 1 more trial

An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in Pediatric Patients (6 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT05694260·31 enrolled

Efficacy and Safety3 trials

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03001076·269 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT03051100·63 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT03193047·59 enrolled

Hyperlipidemia2 trials

Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT02991118·779 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT02988115·345 enrolled

Efficacy2 trials

A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid

Recruiting·GGan & Lee Pharmaceuticals.·Phase 3·NCT06780410·240 enrolled

A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06742853·81 enrolled

Atorvastatin2 trials

A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07235189·58 enrolled

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07268625·58 enrolled

16 more indications

Statin2 trials

Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07201545·58 enrolled

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07182383·58 enrolled

Safety and Efficacy2 trials

Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03067441·1,462 enrolled

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03337308·382 enrolled

Inflammation1 trial

Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)

Recruiting·PPriscilla Hsue, MD·Phase 2·NCT05488431·121 enrolled

Concentration1 trial

Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women

Completed·EEsperion Therapeutics, Inc.·Phase 4·NCT06021951·16 enrolled

Fasting Conditions1 trial

Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06923956·14 enrolled

Cardiovascular Disease1 trial

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT02993406·13,970 enrolled

Prevention1 trial

Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability

Not yet recruiting·SSohaib Ashraf·Phase 3·NCT07239414·690 enrolled

OIC1 trial

Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT07170852·32 enrolled

Pregnancy1 trial

Bempedoic Acid Pregnancy Surveillance Program

Recruiting·EEsperion Therapeutics, Inc.··NCT05103254·20 enrolled

Alcoholic Fatty Liver Disease1 trial

Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes

Recruiting·MMedanta, The Medicity, India·N/A·NCT06035874·100 enrolled

Treatment1 trial

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy

Recruiting·FFederico II University··NCT07374861·1,500 enrolled

Coronary Atherosclerosis1 trial

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

Not yet recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT07474649·103 enrolled

Acute Coronary Syndromes1 trial

EARLY-BIRD ACS Trial: Early Aggressive Lipid-Lowering Regimen With Bempedoic Acid Initiated for Reducing Dyslipidemia in Patients With Acute Coronary Syndrome

Recruiting·TTaipei Medical University Hospital·Approved·NCT07824323·400 enrolled

Primary1 trial

Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo··NCT06686615·2,000 enrolled

ADPKD (Autosomal Dominant Polycystic Kidney Disease)1 trial

Bempedoic Acid Therapy for Polycystic Kidney Disease (BEAT-PKD) Randomized Clinical Trial

Not yet recruiting·KKenneth Hallows·Phase 2·NCT07282821·120 enrolled

Type 2 Diabetes Mellitus1 trial

Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol

Completed·BBahria University·Approved·NCT07255820·126 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 21, 2020

NEXLETOL

NDA NDA211616

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Bempedoic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lesinurad drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bempedoic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bempedoic acid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211616). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lesinurad. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Esperion Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: ATP-Citrate Synthase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EEsperion Therapeutics, Inc.

Patent Landscape[6]

Patent Cliff

Mar 14, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11744816Mar 14, 2036

12398087Jun 19, 2040

Lesinurad

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Q4 2028

Trials by Indication[1]

Hypercholesterolemia4 trials

Efficacy and Safety3 trials

Hyperlipidemia2 trials

Efficacy2 trials

Atorvastatin2 trials

Statin2 trials

Safety and Efficacy2 trials

Inflammation1 trial

Concentration1 trial

Fasting Conditions1 trial

Cardiovascular Disease1 trial

Prevention1 trial

OIC1 trial

Pregnancy1 trial

Alcoholic Fatty Liver Disease1 trial

Treatment1 trial

Coronary Atherosclerosis1 trial

Acute Coronary Syndromes1 trial

Primary1 trial

ADPKD (Autosomal Dominant Polycystic Kidney Disease)1 trial

Type 2 Diabetes Mellitus1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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